Skip to main content
OpenTrials
Completed

NCT Number: NCT02228707

Study to Assess the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

The primary objectives of the study are to evaluate the safety and tolerability of multiple doses of BIIB061 administered to healthy adults. The secondary objective is to determine the multiple-dose PK profile of BIIB061 in this study population.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Age range

20 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Research Site

Madison, Wisconsin, 53704, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

  • Males and postmenopausal (defined as no menses for 12 months and confirmed by follicle-stimulating hormone [FSH] levels determined at screening to be in the postmenopausal range) or surgically sterile females
  • Must be in good health and have normal vital signs as determined by the Investigator, based on medical history and screening evaluations.
  • Must agree to abstain from alcohol ingestion for the duration of the study.
  • Must agree to abstain from consumption of grapefruit or grapefruit-containing products for the duration of the study, starting at least 24 hours prior to admission to the inpatient facility.
  • Must agree to abstain from taking St. John's Wort (herbal preparation) for the duration of the study
  • Must agree to abstain from any vigorous exercise (as determined by the Investigator) for the duration of the study.
  • Must have a body mass index of 18 to 30 kg/m2, inclusive.

Key Exclusion Criteria:

  • History of or positive test result at screening for human immunodeficiency virus, hepatitis C virus antibody, or hepatitis B virus (defined as positive for hepatitis B surface antigen [HBsAg] or hepatitis B core antibody [HBcAb]).
  • Presence of a metal device (e.g., any type of electronic, mechanical, or magnetic implant; cardiac pacemaker; aneurysm clips; implanted cardiac defibrillator) or potential ferromagnetic foreign body (metal slivers, metal shavings, other metal objects) that are contraindications for MRI.
  • History of asthma, wheezing, allergies involving the lungs, or airway obstruction.
  • History of bronchodilator or inhaler use.
  • Clinically significant abnormal hematology or blood chemistry values, as determined by the Investigator.
  • Inability or unwillingness to comply with study requirements.
  • Other unspecified reasons that, in the opinion of the Investigator or Biogen Idec, make the subject unsuitable for enrollment.

Note: Other protocol defined inclusion/ exclusion criteria may apply.

Treatment and study plan

BIIB061

Drug

Participants receive BIIB061

Placebo

Other

Matched placebo

Primary outcomes

  1. Number of participants experiencing AEs

    Time frame: Up to 28 days post treatment period (Day 1 to Day 56)

Secondary outcomes

  1. Plasma BIIB061 Concentration

    Time frame: Up to 28 days post treatment period (Day 1 to Day 56)

Sponsors and collaborators

Lead sponsor

Biogen

Industry

Registry information

Official study title

A Randomized, Double-Blind, Placebo-Controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of BIIB061 in Healthy Adult Volunteers

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Aug 29, 2014
Registry last updated
Jun 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.